Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2024 Financial Results
Aligos Therapeutics (ALGS) reported its Q4 and full year 2024 financial results, highlighting significant progress in its pipeline. The company completed a $105 million private placement in February 2025. Their lead candidate ALG-000184, a CAM-E therapy for chronic hepatitis B virus infection, showed promising Phase 1 results with 100% HBV DNA suppression in tested subjects.
Financial results showed a net loss of $82.2 million for Q4 2024 ($13.08 per share), compared to $27.9 million loss in Q4 2023. Full-year 2024 net loss was $131.2 million. Cash position stood at $56.9 million as of December 31, 2024. The recent financing is expected to fund operations into second half of 2026.
R&D expenses decreased to $16.0 million in Q4 2024 from $22.3 million in Q4 2023. G&A expenses reduced to $5.2 million from $6.4 million in the same period. The company plans to begin Phase 2 studies for ALG-000184 in mid-2025.
Aligos Therapeutics (ALGS) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nel suo pipeline. L'azienda ha completato un collocamento privato di 105 milioni di dollari a febbraio 2025. Il loro candidato principale, ALG-000184, una terapia CAM-E per l'infezione da virus dell'epatite B cronica, ha mostrato risultati promettenti nella Fase 1 con una soppressione del DNA dell'HBV del 100% nei soggetti testati.
I risultati finanziari hanno mostrato una perdita netta di 82,2 milioni di dollari per il quarto trimestre del 2024 (13,08 dollari per azione), rispetto a una perdita di 27,9 milioni di dollari nel quarto trimestre del 2023. La perdita netta per l'intero anno 2024 è stata di 131,2 milioni di dollari. La posizione di liquidità si attestava a 56,9 milioni di dollari al 31 dicembre 2024. Il recente finanziamento è previsto per sostenere le operazioni fino alla seconda metà del 2026.
Le spese per R&S sono diminuite a 16,0 milioni di dollari nel quarto trimestre del 2024 rispetto ai 22,3 milioni di dollari nel quarto trimestre del 2023. Le spese generali e amministrative sono state ridotte a 5,2 milioni di dollari rispetto ai 6,4 milioni di dollari nello stesso periodo. L'azienda prevede di avviare gli studi di Fase 2 per ALG-000184 a metà del 2025.
Aligos Therapeutics (ALGS) informó sobre sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en su pipeline. La compañía completó un colocación privada de 105 millones de dólares en febrero de 2025. Su candidato principal, ALG-000184, una terapia CAM-E para la infección crónica por el virus de la hepatitis B, mostró resultados prometedores en la Fase 1 con una supresión del ADN del VHB del 100% en los sujetos evaluados.
Los resultados financieros mostraron una pérdida neta de 82,2 millones de dólares para el cuarto trimestre de 2024 (13,08 dólares por acción), en comparación con una pérdida de 27,9 millones de dólares en el cuarto trimestre de 2023. La pérdida neta del año completo 2024 fue de 131,2 millones de dólares. La posición de efectivo se situó en 56,9 millones de dólares al 31 de diciembre de 2024. Se espera que el financiamiento reciente financie las operaciones hasta la segunda mitad de 2026.
Los gastos de I+D disminuyeron a 16,0 millones de dólares en el cuarto trimestre de 2024 desde 22,3 millones de dólares en el cuarto trimestre de 2023. Los gastos generales y administrativos se redujeron a 5,2 millones de dólares desde 6,4 millones de dólares en el mismo período. La compañía planea comenzar estudios de Fase 2 para ALG-000184 a mediados de 2025.
알리고스 테라퓨틱스 (ALGS)는 2024년 4분기 및 전체 연도 재무 결과를 보고하며 파이프라인에서의 중요한 진전을 강조했습니다. 회사는 2025년 2월에 1억 5백만 달러의 사모펀드를 완료했습니다. 그들의 주요 후보인 ALG-000184는 만성 B형 간염 바이러스 감염을 위한 CAM-E 치료제로, 시험 대상자에서 100% HBV DNA 억제를 보여주는 유망한 1상 결과를 보였습니다.
재무 결과는 2024년 4분기에 8220만 달러의 순손실을 기록했으며 (주당 13.08달러), 2023년 4분기에는 2790만 달러의 손실을 기록했습니다. 2024년 전체 연도의 순손실은 1억 3120만 달러였습니다. 2024년 12월 31일 기준 현금 보유액은 5690만 달러였습니다. 최근 자금 조달은 2026년 하반기까지 운영을 지원할 것으로 예상됩니다.
연구 및 개발 비용은 2024년 4분기에 2023년 4분기 2230만 달러에서 1600만 달러로 감소했습니다. 일반 및 관리 비용은 같은 기간 동안 640만 달러에서 520만 달러로 줄었습니다. 회사는 2025년 중반에 ALG-000184의 2상 연구를 시작할 계획입니다.
Aligos Therapeutics (ALGS) a publié ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en évidence des progrès significatifs dans son pipeline. La société a complété un placement privé de 105 millions de dollars en février 2025. Leur candidat principal, ALG-000184, une thérapie CAM-E pour l'infection chronique par le virus de l'hépatite B, a montré des résultats prometteurs lors de la phase 1 avec une suppression de l'ADN du VHB de 100 % chez les sujets testés.
Les résultats financiers ont montré une perte nette de 82,2 millions de dollars pour le quatrième trimestre de 2024 (13,08 dollars par action), contre une perte de 27,9 millions de dollars au quatrième trimestre de 2023. La perte nette pour l'année entière 2024 s'élevait à 131,2 millions de dollars. La position de liquidités était de 56,9 millions de dollars au 31 décembre 2024. Le financement récent devrait permettre de financer les opérations jusqu'à la seconde moitié de 2026.
Les dépenses de R&D ont diminué à 16,0 millions de dollars au quatrième trimestre de 2024, contre 22,3 millions de dollars au quatrième trimestre de 2023. Les dépenses générales et administratives ont été réduites à 5,2 millions de dollars, contre 6,4 millions de dollars pendant la même période. La société prévoit de commencer les études de phase 2 pour ALG-000184 à la mi-2025.
Aligos Therapeutics (ALGS) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und erhebliche Fortschritte in seiner Pipeline hervorgehoben. Das Unternehmen hat im Februar 2025 eine Private Placement in Höhe von 105 Millionen Dollar abgeschlossen. Ihr Hauptkandidat ALG-000184, eine CAM-E-Therapie für chronische Hepatitis-B-Virus-Infektionen, zeigte vielversprechende Ergebnisse in der Phase 1 mit einer 100%igen HBV-DNA-Suppression bei getesteten Probanden.
Die finanziellen Ergebnisse zeigten einen Nettoverlust von 82,2 Millionen Dollar für das vierte Quartal 2024 (13,08 Dollar pro Aktie), verglichen mit einem Verlust von 27,9 Millionen Dollar im vierten Quartal 2023. Der Nettoverlust für das gesamte Jahr 2024 betrug 131,2 Millionen Dollar. Die Liquiditätsposition betrug zum 31. Dezember 2024 56,9 Millionen Dollar. Die jüngste Finanzierung wird voraussichtlich die Operationen bis zur zweiten Hälfte des Jahres 2026 unterstützen.
Die F&E-Ausgaben sanken im vierten Quartal 2024 auf 16,0 Millionen Dollar von 22,3 Millionen Dollar im vierten Quartal 2023. Die allgemeinen und administrativen Ausgaben wurden im gleichen Zeitraum auf 5,2 Millionen Dollar von 6,4 Millionen Dollar gesenkt. Das Unternehmen plant, Mitte 2025 mit den Phase-2-Studien für ALG-000184 zu beginnen.
- Successful completion of $105M private placement financing
- 100% HBV DNA suppression achieved in Phase 1 trial for ALG-000184
- Reduced R&D expenses to $16.0M in Q4 2024 from $22.3M in Q4 2023
- Decreased G&A expenses to $5.2M from $6.4M year-over-year
- Net loss increased to $82.2M in Q4 2024 from $27.9M in Q4 2023
- Significant $60.8M loss from change in fair value of common warrants
- Cash position declined to $56.9M from $135.7M year-over-year
Insights
Aligos Therapeutics' latest results reveal compelling clinical progress across their pipeline. Their lead hepatitis B candidate, ALG-000184, continues to demonstrate impressive efficacy with
The planned advancement to Phase 2 by mid-2025 represents a significant milestone, particularly as management positions this compound as potentially first- and best-in-class with backbone therapy potential. The drug's mechanism as a capsid assembly modulator (CAM-E) targets a fundamental viral replication process, potentially offering advantages over current standard of care.
For their MASH program, ALG-055009 demonstrated placebo-adjusted median relative liver fat reductions up to
While management indicated they're exploring out-licensing options for the MASH program, this reflects appropriate resource allocation rather than doubting the asset's potential. Overall, the clinical data across multiple programs demonstrates meaningful scientific progress with potential therapeutic value.
Aligos' financial position has been substantially strengthened by their
The headline Q4 net loss of
R&D expenses decreased to
The company's strategy of seeking external funding for their coronavirus program while potentially out-licensing their MASH candidate shows disciplined capital allocation, allowing them to concentrate resources on their lead hepatitis B program. With sufficient capital secured and promising clinical data, Aligos is well-positioned to execute on their development plans through multiple value-creating milestones.
SOUTH SAN FRANCISCO, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2024.
“2024 was a pivotal year for the company, paving the way for the future of Aligos,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025. We continue to believe our CAM-E has the potential to be a first- and best-in-class candidate, by acting as a disease modifying agent for patients in need of better outcomes. Our recent fundraising is backed by investors supportive of our vision for ALG-000184, which has the potential to replace standard of care and become the backbone of treatment for next-generation therapies for chronic hepatitis B virus infection.”
Recent Business Progress
Corporate Updates
- Lesley Ann Calhoun was promoted to Executive Vice President, Chief Operating Officer and Chief Financial Officer
- The Company completed a
$105 million private placement financing on February 13, 2025, which included participation from both new and existing institutional investors
Pipeline Updates
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus infection
- Dosing continues in the ongoing Phase 1 study, with subjects expected to dose for up to 96 weeks. 96-week data readouts are planned to be presented this year at upcoming scientific conferences
- Interim data from up to 92 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic hepatitis B virus infection were presented at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024
- Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 7/7 (
100% ) HBeAg-positive subjects - All HBeAg- subjects achieved sustained HBV DNA suppression by Week 24 and 11/11 (
100% ) subjects achieved sustained HBV DNA <LLOQ at Week 48 with 10/11 (91% ) subjects further achieving HBV DNA below the lower limit of detection (LLOD <4.29 IU/mL) - Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment
- Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 7/7 (
- The Phase 2 study is expected to begin in mid-2025
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
- The Phase 2a HERALD data were presented at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF
- Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to
46.2% as measured by MRI-PDFF. Up to70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline, a positive prognostic indicator of histological improvements in MASH resolution and fibrosis reduction - Eighteen subjects who were on stable GLP-1 agonist therapy qualified for enrollment in the study, with liver fat content meeting the inclusion criteria of ≥
10% at baseline as measured by MRI-PDFF. Notably, 11/14 subjects on stable GLP-1 agonists treated with ALG-055009 had liver fat decreases, whereas 4/4 subjects on stable GLP-1 agonists treated with placebo had increases in liver fat over the 12-week dosing period - Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) and apolipoprotein B and dose-dependent increases in SHBG were observed. In particular, ALG-055009 demonstrated a dose-dependent reduction from baseline of up to
26.8% at Week 12 for lipoprotein (a), which is an established risk factor for cardiovascular disease that has been resistant to treatment with statin therapy - Treatment with ALG-055009 was well-tolerated, with rates of gastrointestinal-related AEs similar to placebo
- Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to
- The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor
- Three additional clinical trials evaluating ALG-097558 commenced in 2024
- AGILE University of Liverpool, a UK government supported platform trial (MRC and Wellcome Trust funding), is sponsoring and performing a study in high-risk COVID-19 patients evaluating ALG-097558 as monotherapy or in combination with remdesivir
- Clinical studies evaluating PK in special populations (renal and hepatic impairment subjects; NIAID contract) are on-going
- The NIAID is also sponsoring a drug-drug interaction and relative bioavailability study in healthy volunteers that is expected to start dosing in the second quarter of 2025
- The company expects any future development of ALG-097558, including ongoing Phase 2 enabling activities, to be funded by external sources
Financial Results for the Fourth Quarter 2024
Cash, cash equivalents and investments totaled
Net loss for the three months ended December 31, 2024 was
Net loss for the year ended December 31, 2024 was
Research and development (R&D) expenses for the three months ended December 31, 2024 were
R&D expenses for the year ended December 31, 2024 were
General and administrative (G&A) expenses for the three months ended December 31, 2024 were
G&A expenses for the year ended December 31, 2024 were
Interest and other income, net, for the three months ended December 31, 2024 was loss of
Interest and other income, net, for the year ended December 31, 2024 was income of
Change in fair value of common warrants for the three months ended December 31, 2024 was a loss of
Change in fair value of common warrants for the year ended December 31, 2024 was a loss of
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the expectation that a Phase 2 clinical study for ALG-000184 will begin in mid-2025; the potential of CAM-E and ALG-000184; the continuation of dosing in the ongoing Phase 1 study for ALG-000184 with subjects planning to dose for up to 96 weeks and the planned presentation at upcoming scientific conferences; the expectation of continued development and out-licensing for ALG-05509 and future development of ALG-097558; and the company’s continued belief its cash, cash equivalents and investments provide sufficient funding of fund planned operations through the second half of 2026. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2024 and Aligos’ Annual Report on Form 10-K to be filed with the Securities and Exchange Commission on March 10, 2025 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
| Aligos Therapeutics, Inc | ||||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||||
| December 31, | December 31, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Audited)(1) | |||||||||||||||
| Revenue from Collaborations | 23 | 2,009 | 334 | 9,338 | ||||||||||||||
| Revenue from Customers | 606 | 672 | 3,611 | 6,191 | ||||||||||||||
| Operating Expenses: | ||||||||||||||||||
| Research and development | 16,031 | 22,257 | 70,269 | 73,040 | ||||||||||||||
| General and administrative | 5,161 | 6,421 | 22,830 | 30,616 | ||||||||||||||
| Total operating expenses | 21,192 | 28,678 | 93,099 | 103,656 | ||||||||||||||
| Loss from operations | (20,563 | ) | (25,997 | ) | (89,154 | ) | (88,127 | ) | ||||||||||
| Interest and other income (loss), net | (788 | ) | 244 | 4,406 | 3,412 | |||||||||||||
| Change in fair value of common warrants | (60,772 | ) | (2,169 | ) | (46,132 | ) | (2,169 | ) | ||||||||||
| Loss before income tax provision | (82,123 | ) | (27,922 | ) | (130,880 | ) | (86,884 | ) | ||||||||||
| Income tax provision | (27 | ) | 30 | (331 | ) | (795 | ) | |||||||||||
| Net loss | (82,150 | ) | (27,892 | ) | (131,211 | ) | (87,679 | ) | ||||||||||
| Basic and diluted net loss per common share | ) | ) | ) | ) | ||||||||||||||
| Weighted-average shares common stock, basic and diluted | 6,282,056 | 5,069,035 | 6,264,612 | 2,563,470 | ||||||||||||||
| Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) | ||||||
| December 31, 2024 | December 31, 2023 | |||||
| (Unaudited) | (audited) (1) | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 36,997 | $ | 135,704 | ||
| Short-term investments | 19,942 | - | ||||
| Prepaid expenses and other current assets | 5,202 | 5,380 | ||||
| Total current assets | 62,141 | 141,084 | ||||
| Other assets | 7,953 | 10,443 | ||||
| Total assets | $ | 70,094 | $ | 151,527 | ||
| Liabilities and Stockholders’ (Deficit) Equity | ||||||
| Current liabilities | $ | 21,737 | $ | 23,906 | ||
| Other liabilities, noncurrent | 77,330 | 35,541 | ||||
| Total liabilities | 99,067 | 59,447 | ||||
| Total stockholders’ (deficit) equity | (28,973 | ) | 92,080 | |||
| Total liabilities and stockholders’ (deficit) equity | $ | 70,094 | $ | 151,527 | ||
_____________________________________________
(1) The condensed, consolidated statement of operations for the year ended December 31, 2023, and balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
FAQ
What were the key findings from ALG-000184's Phase 1 trial for hepatitis B treatment?
How much cash does ALGS have after the recent private placement?
What caused ALGS's increased net loss in Q4 2024?
When will ALGS begin Phase 2 trials for ALG-000184?
